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March 15th, 2004
"FDA Sued Over Failure to Act on Petition for a Serzone Recall"
Public Citizen has sued the FDA, calling the agency "grossly negligent" for failing to issue a Serzone ban despite having already been taken off the market in Canada and Europe, with sales to end in Australia and New Zealand in May. The consumer watchdog group thinks that the need to sue the federal agency is "a shame" and is now trying to force the ban after waiting a year for action following its first petition.
In January 2002, a "black box" warning was added to Serzone packing inserts to warn of life-threatening liver damage. Despite the strongest issued FDA drug warning, Serzone side effects failed to decrease, which is typically seen among older medications. When Public Citizen first sought a Serzone ban in March 2003, the group cited 21 cases of liver failure and 11 deaths between when Serzone was first marketed in 1994 and the spring of 2002.
In October 2003, Public Citizen issued a supplemental petition after the Serzone side effects increased to 55 cases of liver failure, including 20 deaths and another 39 cases of less severe liver injury reported to the FDA. The Serzone side effects were especially concerning because the FDA estimates its monitoring system counts fewer than 10 percent of the side effects caused by medications.
Arguing the warnings have failed to so far help, Public Citizen has now asked a federal judge to declare the FDA''s delay illegal and force the drug agency to act to fulfill its obligation to "protect public safety and prevent needless death and injury". Marketed by Bristol-Myers Squibb, the consumer group also noted that Serzone works no better than older, safer antidepressants.
